NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) | PAR 18 684

Opportunity Information: Apply for PAR 18 684

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required), PAR 18-684, is a National Institutes of Health grant opportunity designed to fund investigator-initiated phase I clinical trials focused on new diagnostic or therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The central aim is to help move promising interventions into early human testing, with the expectation that applicants are proposing a study that meets the NIH definition of a clinical trial and clearly aligns with the NHLBI mission and research priorities. Trials may be conducted at a single site or across multiple sites, depending on what best fits the clinical question, recruitment needs, and operational realities of the project.

A defining feature of this opportunity is its bi-phasic, milestone-driven structure. In practice, that means the award is set up in two parts, with explicit performance benchmarks that must be met to progress. The first phase is intended to support critical pre-trial start-up activities that are often required before enrollment can begin, such as product stability work, shipping and handling studies, and training clinical sites so procedures are consistent and trial-ready. The second phase is where the clinical trial itself is carried out. Because the mechanism is milestone-based, applicants are expected to propose clear, measurable milestones tied to both scientific goals and operational deliverables, and to show they have a realistic plan to meet them.

Applications are expected to go beyond a basic study synopsis and instead provide a strong scientific rationale for why the intervention should be tested in humans at this stage, along with a detailed scientific and operational plan. That plan should cover how the trial will be managed day-to-day, how participants will be recruited and retained, how data and safety will be handled, what the key timelines and decision points are, and how results will be analyzed and disseminated. The FOA signals that NHLBI is looking for well-prepared teams that can execute an early phase trial responsibly, including attention to practical issues that can derail trials, like site readiness, participant enrollment challenges, and product logistics.

Team structure is an important emphasis. While not mandatory, the multiple PD/PI model is strongly encouraged, reflecting how early phase trials often require a blend of leadership across clinical expertise, trial operations, and product development. Applicants are encouraged to assemble teams with capabilities in biostatistics, clinical trial design, and trial coordination, as well as manufacturing and formulation expertise when relevant to the therapeutic or diagnostic being tested. Because of the complexity and regulatory considerations involved in conducting clinical trials, prospective applicants are strongly encouraged to contact the designated NHLBI scientific/research staff prior to submission. The intent is that NHLBI staff can help applicants interpret expectations, ensure alignment with the FOA, and troubleshoot common planning gaps before an application is finalized.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible organization types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations and U.S. territories or possessions.

Foreign eligibility is more limited. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning parts of the work can be conducted outside the U.S. when appropriately justified and structured under a U.S. applicant organization.

From the funding details provided, this is a discretionary NIH grant in the health area (CFDA numbers listed include 93.233 and 93.837-93.839), with an award ceiling of $1,515,000. The opportunity was created on February 27, 2018, and the original closing date listed is January 7, 2021. Overall, the FOA is geared toward applicants who are ready to run a rigorously planned phase I trial and who can demonstrate both the scientific premise for testing the intervention and the operational readiness to carry out the study under a milestone-based award structure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839.
• This funding opportunity was created on 2018-02-27.
• Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,515,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 684

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